Frequently Asked Questions (FAQS) About 2009 H1N1 Influenza Virus Testing

Not sure what your options are for testing for the 2009 H1N1 influenza virus? Unclear how the company's 2009 H1N1 influenza virus tests differ from other influenza tests? Read our comprehensive FAQs for answers to your most common questions about influenza testing.

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General FAQS

1. What is the 2009 H1N1 influenza virus?

The 2009 H1N1 influenza virus is a subtype of influenza virus type A. It causes respiratory illness in some individuals infected with the virus. It is a new virus that has never before circulated among humans. It is not related to previous or current human seasonal influenza viruses. Like seasonal flu, disease caused by the 2009 H1N1 influenza virus in humans can vary in severity from mild to severe.

The Centers for Disease Control and Prevention (CDC) has determined that this virus, which was first identified in Spring 2009, is contagious and is spreading from person to person. In mid-June 2009, the World Health Organization (WHO) reported cases of infection with the virus in more than 70 countries and declared it a phase 6 pandemic. The WHO reported that as of November 1, 2009, worldwide more than 199 countries have reported confirmed cases of 2009 H1N1 pandemic influenza, including over 6000 deaths.

2. Does Quest Diagnostics provide 2009 H1N1 influenza virus testing?

Yes. Quest Diagnostics currently performs the Influenza A H1N1 (2009) Real-Time RT-PCR test* at select laboratories in its national network. The company's Focus Diagnostics business developed the test earlier this year. The FDA issued an emergency use authorization for the test in July 2009. The test uses real-time reverse-transcriptase polymerase chain reaction (RT-PCR) to target two separate regions of the hemagglutinin gene of the 2009 H1N1 influenza virus to differentiate the presence of the pandemic virus from seasonal human influenza A virus. For more information, please refer to the Product Insert. The test is also available for sale as a test kit to CLIA high-complexity laboratories.

In addition, the FDA authorized for emergency use an additional Focus Diagnostics test in October 2009. The Simplexa™ Influenza A H1N1 (2009) Test on the 3M™ Integrated Cycler test* is currently available for sale as a test kit to CLIA high-complexity laboratories. The test targets a region of the hemagglutinin gene of the 2009 H1N1 influenza virus to differentiate the presence of the 2009 H1N1 flu virus from seasonal human influenza A viruses. For more information, please refer to the Product Insert.

At the present time, Quest Diagnostics provides laboratory testing services for 2009 H1N1 influenza using the Influenza A H1N1 (2009) Real-Time RT-PCR test.

 The Simplexa™ Influenza A H1N1 (2009) Test
on the 3M™ Integrated Cycler

*These H1N1 tests have not been FDA cleared or approved. These H1N1 tests have been authorized by FDA under an Emergency Use Authorization (EUA). These H1N1 tests are only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1). The declaration of emergency will expire on June 23, 2010, unless it is terminated or revoked sooner or renewed.

3. How do the company’s 2009 H1N1 influenza virus testing capabilities differ from other laboratory companies?

As the leading diagnostic testing company, Quest Diagnostics is at the forefront of the industry in developing new testing innovations for infectious diseases, including the 2009 H1N1 influenza virus. Through our Focus Diagnostics business, we were the first to:

  • develop a commercial test for detecting the 2009 H1N1 influenza virus - in fact, we launched it a little more than two weeks after the genetic code of the novel virus was publicly available;
  • receive an EUA from the FDA for a commercial 2009 H1N1 influenza virus test;
  • receive another EUA for pandemic testing -- this time for our next generation Simplexa Influenza A H1N1 (2009) Test on the 3M™ Integrated Cycler; and
  • perform laboratory testing using our 2009 H1N1 influenza virus test while also distributing for purchase our two 2009 H1N1 influenza virus test kits to other CLIA high complexity laboratories.

We believe we are the only company in the world to offer high quality RT-PCR laboratory testing using tests authorized for emergency use by FDA for detecting the RNA of the pandemic virus and to distribute two RT-PCR test kits with emergency use authorization for detecting the virus to high complexity labs.

4. Can the company’s 2009 H1N1 influenza virus tests detect seasonal flu viruses as well as the pandemic virus?

Yes. They report positive or negative results for detecting the RNA of the 2009 H1N1 influenza virus. They also report positive or negative results for detecting the RNA of certain seasonal flu viruses. In this way, they aid in differentiating the presence of the 2009 H1N1 flu virus from seasonal human influenza A viruses in a specimen.

5. What are the differences between the two test kits that the FDA has authorized for emergency use?

The performance is similar, but they operate on different equipment. The Influenza A H1N1 (2009) Real Time RT-PCR runs on equipment from Roche and Applied Biosystems, while the Simplexa Influenza A H1N1 (2009) Test runs on the 3M™ Integrated Cycler.

6. How accurate are the company’s 2009 H1N1 influenza virus tests?

The tests’ performance is equivalent to the test that public health laboratories in the U.S. use to confirm a diagnosis of H1N1. The FDA provided us with emergency use authorization after we demonstrated the tests' comparable level of performance.

7. What does RT-PCR mean?

Polymerase chain reaction, or PCR, is a process of amplifying a specific DNA sequence in order to make it detectable. Reverse transcriptase, or RT, refers to a step that must be performed when testing RNA (e.g., cold and flu viruses, as well as many others) using PCR.

8. Didn't the company launch its first H1N1 flu test in May 2009?

Yes. Focus Diagnostics developed and launched its first test in May 2009. The test was launched as a laboratory developed test in compliance with federal regulations defined in the Clinical Laboratory Improvement Amendments (CLIA).

9. If the test was launched in May, why is emergency use authorization for the test important?

The FDA’s decision to grant our 2009 H1N1 influenza tests emergency use authorizations means that Focus Diagnostics now not only continue to provide 2009 H1N1 testing services using its FDA EUA tests, but also can offer the tests as kits to other CLIA high-complexity laboratories, provided they also run the necessary equipment and meet other requirements for performing the tests. Our new tests can help expand the nation's capacity to perform high quality H1N1 testing for the pandemic health emergency.

10. What is an emergency use authorization (EUA)?

The U.S. Food and Drug Administration has issued emergency use authorizations to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the 2009 H1N1 influenza virus under certain circumstances. There are no FDA cleared or approved tests for the identification of the 2009 H1N1 influenza virus. The EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met.

11. Are your 2009 H1N1 influenza virus tests FDA approved?

No. The FDA has not cleared or approved our 2009 H1N1 influenza virus tests. However; the FDA has issued emergency use authorizations to our 2009 H1N1 influenza test kits.

12. Have other organizations received EUAs?

The FDA has issued emergency use authorization (EUA) for 2009 H1N1 influenza virus tests using RT-PCR to the U.S. Centers for Disease Control and Prevention. U.S. public health laboratories perform these tests. In addition to our 2009 H1N1 influenza virus tests, the FDA has issued EUAs for select commercial tests. We were the first to offer a commercial test that was authorized for emergency use by the FDA.

13. What are the public health reporting requirements for confirmatory testing of test results that test positive for the 2009 H1N1 influenza virus?

When the emergency initially began, public health departments generally required that samples that tested positive for Influenza A virus be forwarded to the appropriate public health laboratory for further testing for the presence of the 2009 H1N1 influenza virus. Since that time, most public health laboratories only require that positive influenza A virus samples be forwarded for confirmatory testing for patients considered high risk or with severe disease. These requirements differ by state and, in certain cases, by county.

We believe that most public health departments do not require laboratories performing our tests to forward positive samples to the public health lab for confirmatory testing. However, public health guidelines vary by state and county level, and are subject to change. We provide influenza virus testing in alignment with these guidelines.

14. Where can I learn more about U.S. public health guidelines?

Quest Diagnostics provides a list of web sites of U.S. state and county public health authorities as a resource to physicians.

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Physician FAQS

15. I am a physician. How may I speak to a Quest Diagnostics medical expert about my clinical concerns related to influenza?

Quest Diagnostics operates laboratories in many cities across the U.S. Our Medical Directors at these laboratories are available to answer questions from our physician clients. Please visit our Facilities page and refer to the section titled “Quest Diagnostics Major Laboratory Facilities” to identify the location and phone number of a Quest Diagnostics clinical laboratory in the city nearest you. When calling, please indicate that you wish to speak with a Medical Director about influenza testing.

16. Why should I order testing for 2009 H1N1 influenza for my patient?

Test results may help clinicians manage patients and evaluate treatment options. For information on testing guidelines, please refer to the CDC's web site at CDC at http://www.cdc.gov/h1n1flu/diagnosis/.

17. What is the turnaround time for reporting results?

Results may be reported within 24 hours after the 2009 H1N1 influenza virus testing laboratory receives a sample. Physicians should keep in mind that the receiving laboratory may not perform the test on-site and will therefore send the sample to one of the Quest Diagnostics laboratories that performs the test; this could add 24 to 48 hours to the turnaround time.

18. What are the acceptable sample types for testing?

Quest Diagnostics currently performs the Influenza A H1N1 (2009) Real-Time RT-PCR test at select Quest Diagnostics laboratories in the U.S. The acceptable sample types for this test are nasopharyngeal swabs, nasal swabs, throat swabs or nasal aspirates in viral transport media V-C-M medium (green-cap) tube or equivalent (UTM), or Multi Microbe Media (M4). If using swabs, use only sterile Dacron, nylon, or rayon swabs with plastic shafts. Do not use calcium alginate swabs, as they may contain substances that inhibit PCR testing.

19. How do RT-PCR tests for 2009 H1N1 influenza compare to other common flu tests?

Both have advantages and disadvantages. Rapid tests are generally reliable at reporting positive test results. They can also produce results in a clinically relevant time period (i.e., 30 minutes or less) to inform clinical decision making. Disadvantages include an inability to distinguish between H1N1 and seasonal influenza A subytpes, and low to moderate sensitivity compared to viral culture or RT-PCR.

By comparison, RT-PCR is often performed in a complex molecular laboratory. Sending specimens to a lab that can perform this type of testing means results typically take a day or longer to report back to a physician. (Molecular hospital labs that meet the requirements to perform our 2009 H1N1 test kits may be able to provide results much faster to physicians treating patients in a hospital.) On the other hand, RT-PCR is generally considered highly reliable, and some RT-PCR tests, like those that we offer, can aid in differentiating between the 2009 H1N1 and seasonal flu viruses.

According to guidelines from the CDC, “clinicians should be aware that the sensitivities of rapid influenza diagnostic tests (RIDTs) and direct immunofluorescence assays (DFAs) are lower than real-time reverse transcriptase polymerase chain reaction (rRT-PCR) tests and viral culture. A negative RIDT or DFA result does not rule out influenza virus infection …Further, these rapid tests cannot distinguish between 2009 H1N1 and seasonal H1N1 or H3N2 influenza A viruses.”

The CDC also explains in interim recommendations dated October 16, 2009 that “the sensitivity of rapid tests in detecting 2009 H1N1 has ranged from 10% to 70%" and "testing for 2009 H1N1 influenza infection with real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) should be prioritized for persons with suspected or confirmed influenza requiring hospitalization and based on guidelines from local and state health departments.”

20. Is testing for the 2009 H1N1 influenza virus recommended by CDC guidelines?

The CDC guidelines identify those who should be tested. Current recommendations for testing:

  • Most patients with clinical illness consistent with uncomplicated influenza who reside in an area where influenza viruses are circulating do not require diagnostic influenza testing for clinical management.
  • Patients who should be considered for influenza diagnostic testing include:
    • Hospitalized patients with suspected influenza
    • Patients for whom a diagnosis of influenza will inform decisions regarding clinical care, infection control, or management of close contacts.
    • Patients who died of an acute illness in which influenza was suspected.
    • When a decision is made to use antiviral treatment for influenza, treatment should be initiated as soon as possible without waiting for influenza test results. Antiviral treatment is most effective when administered as early as possible in the course of illness. http://www.cdc.gov/h1n1flu/recommendations.htm

21. As a clinician, where can I find out more information about CDC guidelines regarding 2009 H1N1 influenza virus?

Visit www.cdc.gov/h1n1flu. All information and guidelines, including those on testing for 2009 H1N1 influenza A virus, may change as we continue to learn more about this disease. Please check CDC’s 2009 H1N1 influenza virus website regularly for current information.

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Patient FAQS

22. I am a patient. Who can I speak to about my concerns about this pandemic?

We encourage concerned patients to talk directly with their physicians.

23. Can I go directly to a Quest Diagnostics Patient Service Center to be tested for the pandemic virus?

No. Your physician must order the test and collect the specimen. Please contact your physician for more information.

24. If my physician tests me using one of your 2009 H1N1 flu virus tests and the result is positive, does that mean that I have 2009 H1N1 flu?

Yes, although there is a very small chance that our tests can give a result that is wrong (false positive), it is not likely. If your result is positive, your doctor may decide how to care for you based on the test results along with other factors.

25. If my physician tests me using one of your 2009 H1N1 flu virus tests and the result is negative, does that mean I do not have 2009 H1N1 flu?

If the test is negative you may be sick with something that is not the 2009 H1N1 flu. There is a small chance that our tests can give a result that is wrong (false negative). No changes in your medical care should be solely based on a negative result. Please contact your physician for more information.

26. Will my insurance company pay for these tests?

Any reimbursement depends on the nature of the coverage and the health plan. Please contact your health plan for more information.

27. Where can I go for more information about how to protect against 2009 H1N influenza virus infection?

Please visit the CDC’s web information at http://www.cdc.gov/h1n1flu.

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Laboratorian FAQS

28. Can other clinical laboratories purchase and perform the company's 2009 H1N1 influenza virus test kits?

Yes, assuming they meet the criteria of CLIA high-complexity, operate the necessary equipment, and meet other requirements. They also must publish certain patient and healthcare provider information, report test results to public health authorities, and inform Focus Diagnostics about reports of false positive or negative results.

29. Are the test kits being distributed outside the U.S?

The Simplexa™ Influenza A H1N1 (2009) Test on the 3M™ Integrated Cycler test has been CE marked and is now available for distribution to approximately 35 countries in Europe.

30. Are the tests available for purchase?

Yes. To order the test, please contact Focus Diagnostics at 800-445-0185 (U.S.) or +49-6026-9499540 (Europe). You may also email us at H1N12009@focusdx.com.

31. What is the price of the test kits?

For information on pricing, please contact Focus Diagnostics at 800-445-0185 (U.S. and International) or +49-6026-9499540 (Europe). You may also email us at H1N12009@focusdx.com.

32. Where can I learn more about Focus Diagnostics?

Focus Diagnostics has a track record of being first to market with new testing innovations for emerging infectious diseases. Focus Diagnostics was instrumental in developing the first laboratory developed test for West Nile virus, introduced the first laboratory developed test for SARS and introduced one of the first FDA-cleared serological test kits for Lyme disease. For more information, visit www.FocusDx.com.